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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00158314
Other study ID # R01MH060417-01
Secondary ID R01MH060417-01DA
Status Completed
Phase Phase 1
First received September 7, 2005
Last updated June 28, 2013
Start date March 1998
Est. completion date November 2003

Study information

Verified date June 2013
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness and cost-effectiveness of three different treatment strategies in reducing gambling behaviors.


Description:

The number of pathological gamblers in the United States is steadily growing, leading to significant financial, psychological, and public health consequences. However, studies examining the effectiveness of treatment interventions for pathological gamblers are limited. This study will compare the effectiveness of three different treatment strategies, including referral to Gambler's Anonymous (GA), a self-help manual, and cognitive behavioral therapy (CBT), in reducing gambling behaviors and other problems related to pathological gambling.

This study will last 8 weeks. Participants will be randomly assigned to one of three interventions. Group 1 participants will be referred to GA and 8 weeks of CBT, which focuses on teaching skills to help reduce gambling urges and develop alternative behaviors to gambling. Group 2 participants will be referred to GA and given an 8-week self-help manual. Group 3 participants will be referred to GA alone. Questionnaires will be used to assess participants' gambling behavior and any personal, legal, or health problems they may be experiencing. The questionnaires will be completed at study entry, study completion, and at 6- and 12-month follow-up visits.

Participants will be asked to identify at least one person who knows about their gambling problem and will have regular contact with them during the study and for at least 1 year This person will be interviewed at the beginning of the study, and at Months 2, 6 and 12. Researchers will ask contact persons about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00118391

http://clinicaltrials.gov/show/NCT00618462


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date November 2003
Est. primary completion date November 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of pathological gambling

- 3 or more gambling episodes within 60 days prior to study entry

Exclusion Criteria:

- Inability to read English at the 5th grade level

- Uncontrolled psychiatric condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Referral to Gamblers Anonymous

Cognitive behavioral therapy

Cognitive behavioral self-help manual


Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Health Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Addiction Severity Index (ASI) gambling severity scores
Primary time spent gambling
Primary days of non-gambling
Secondary Psychiatric symptoms
Secondary psychosocial functioning
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